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510(k) K250109

TYBR Collagen Gel by Tybr Health — Product Code OWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2025
Date Received
January 16, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Device Class
Class II
Regulation Number
878.3300
Review Panel
OR
Submission Type

For reinforcement of soft tissue where weakness exists in tendon repair.

Other clearances for product code OWY

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  • K252647 — Tapestry Biointegrative Implant (September 19, 2025)
  • K243843 — Tendon Protect (50242) (June 4, 2025)
  • K242631 — REGENETEN™ Bioinductive Implant (November 26, 2024)
  • K222501 — Regeneten Bioinductive Implant (May 11, 2023)
  • K220867 — Tapestry Biointegrative Implant (May 23, 2022)
  • K212306 — Tapestry Biointegrative Implant (November 2, 2021)
  • K201572 — TAPESTRY Biointegrative Implant (October 19, 2020)
  • K151083 — BioBridge Collagen Matrix (January 8, 2016)
  • K140300 — COLLAGEN TENDON SHEET-DDI (CTS-DDI) (March 26, 2014)